Development of minimum reporting sets of patient characteristics in epidemiological research: a methodological systematic review

Abstract

Background: Core patient characteristic sets (CPCS) are increasingly developed to identify variables that should be reported to describe the target population of epidemiological studies in the same medical area, while keeping the additional burden on the data collection acceptable. Methods: We conduct a systematic review of primary studies/ protocols published aiming to develop CPCS, using the PubMed database. We particularly focus on the study design and the characteristics of the proposed CPCS. Quality of Delphi studies was assessed by a tool prosposed in the literatue. All results are reported descriptively. Results: Among 23 eligible studies, Delphi survey is the most frequently used technique to obtain consensus in CPCS development (69.6%, n=16). Most studies do not include patients as stakeholders. The final CPCS rarely include socioeconomic factors. 60.9% (n=14) and 31.6% (n=6) of studies provide definition and recommend measurement methods for items, respectively. Conclusion: This study identified a considerable variation and suboptimality in many methodological aspects of CPCS studies. To enhance the credibility and adoption of CPCS, a standard for conducting and reporting CPCS studies is warranted.

Population adjusted‐indirect comparisons in health technology assessment: A methodological systematic review

“…18,20,21 While CPCS should be further considered in the future, rationales for covariate selection should always be included when conducting a PAIC analysis. 3,22 Third, we observed that a large number of studies did not assess the potential overlap of covariate distribution between populations before and after adjustment. In a PAIC analysis, although the target populations of different studies might be different, it is important that they are still sufficiently similar so that we can learn about one population via observing the other without erroneous extrapolations.…”

“…Across many therapeutic areas, a so‐called core patient characteristic set (CPCS) is specifically developed to identify all key prognostic factors that should be commonly collected and reported (among studies and databases evaluating a similar target condition), while keeping the additional burden on the implementation acceptable 18,20,21 . While CPCS should be further considered in the future, rationales for covariate selection should always be included when conducting a PAIC analysis 3,22 …”